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Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02862938
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey L Goldberg, Stanford University

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 11, 2016
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
Visual Field [ Time Frame: 6 months ]
Determine the efficacy of NT-501 ECT implant in patients with glaucoma as measured by change in visual field through 6 months as assessed by any one of the following three indices:
  1. Visual Field Index (VFI)
  2. Mean Deviation (MD)
  3. Pointwise linear regression (PLR)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
  • Structural measure of retinal ganglion cell layer thickness [ Time Frame: 6, 12 and 24 months ]
    The change in ganglion cell layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
  • Structural measure of retinal nerve fiber layer thickness [ Time Frame: 6, 12 and 24 months ]
    The change in retinal nerve fiber layer thickness as measured by spectral domain optical coherence tomography (sdOCT).
  • Contrast sensitivity [ Time Frame: 6, 12 and 24 months ]
    The change in contrast sensitivity through 6, 12 and 24 months
  • Best corrected visual acuity [ Time Frame: 6, 12 and 24 months ]
    The change in best corrected visual acuity (BCVA) through 6, 12 and 24 months
  • Optic nerve head structural change [ Time Frame: 6, 12 and 24 months ]
    The change in optic nerve topography as measured by stereo photography through 6, 12, or 24 months 6. The change in visual field as measured by pattern standard deviation (PSD) through 6 months 7. The change in any of the above functional or structural measures at 12 or 24 months
  • Visual field pattern standard deviation [ Time Frame: 6, 12 and 24 months ]
    The change in visual field as measured by pattern standard deviation (PSD) through 6, 12 or 24 months 7. The change in any of the above functional or structural measures at 12 or 24 months
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of NT-501 Encapsulated Cell Therapy for Glaucoma Neuroprotection and Vision Restoration
Official Title  ICMJE A Randomized, Sham Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
Brief Summary

This is a randomized, sham controlled, masked clinical trial of 60 study participants with glaucoma. Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive the NT-501 encapsulated cell therapy (ECT) implant or a sham surgery (control arm), and no explant will be required.

An examination for safety will occur one day and one week following implant and periodically thereafter for 24 months post-implant. Based on the primary analysis of data at 6 months, patients in the control arm may be offered the NT-501 ECT implant at the 12 month time point.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE
  • Drug: NT-501 ECT implant
    NT-501 ECT implant will be placed into the vitreous and out of the visual axis of the study eye. The surgical procedure involves making a small incision through the sclera (white part of the eye), inserting the implant and securing it with a suture.
  • Other: Sham
    Sham surgery
Study Arms  ICMJE
  • Experimental: NT-501 ECT Implant

    On eligible participants that are randomized to this group, the NT-501 Investigational product will be implanted in the study eye, and participants will be followed for 24 months.

    The investigational treatment, NT-501 ECT, provides intravitreal sustained release of soluble ciliary neurotrophic factor (CNTF) receptor after intraocular implantation.

    Intervention: Drug: NT-501 ECT implant
  • Sham Comparator: Sham
    To maintain masking, participants randomized to this group receive sham surgery and will be followed for 12 months. Following analysis of the 6 month data, if the open label extension (OLE) is not triggered, patients in the control group will continue on the original study schedule timeline trough month 24. If OLE is triggered participants will be offered the NT-501 ECT investigational product and will followed for additional 12 months.
    Intervention: Other: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 23, 2019)
54
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
60
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients must meet all of the following criteria to join the study (all eligibility criteria must be met at the screening and baseline visits unless otherwise noted):

  1. Participant must be medically able to undergo the testing required in the schedule of events (SOE).
  2. Participant's clinical diagnosis must be consistent with glaucoma 1. characterized by the following features:

    a) Clinical evidence of progressive retinal ganglion cell (RGC) dysfunction and degeneration using both visual field and at least one structural modality as established by: i. Glaucomatous visual field abnormality. ii. Mean deviation (MD) of -3 to -15 dB. iii. Minimum average retinal nerve fiber layer (RNFL) thickness of 60 μm and maximum average RNFL of 90 μm.

    b) Residual visual field preservation including best-corrected visual acuity (BCVA) better than 20/200 in both eyes.

    c) Two visual field tests of adequate quality with a maximum visual field index (VFI) variability of ± 10%.

  3. Participant's glaucoma must be clinically stable, with intraocular pressure (IOP) < 21.
  4. If a participant has two eyes meeting study criteria, only the worse eye as determined by visual field index (VFI) will be deemed includable. If both eyes qualify and have the same VFI, a randomization procedure will assign one eye to the study.
  5. Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety.
  6. Females of childbearing potential must agree to use an effective form of birth control.
  7. Participant must be determined by the presurgical anesthesia or medical team to be fit for ophthalmic surgery for the NT-501 ECT implant insertion.

Exclusion Criteria:

  1. Participant is unable to comply with study procedures or follow-up visits.
  2. Participant has other optic nerve or retinal degenerative disease causing vision loss, irrespective of whether it is currently treated or untreated.
  3. Participant has visual loss to less than 20/200 in non-study eye.
  4. Participant is likely to be offered glaucoma surgery within 6 months of screening.
  5. Participant has optic nerve atrophy beyond modest pallor.
  6. Participant has cataract-associated vision loss to less than 20/40.
  7. Participant has a history of ocular herpes zoster.
  8. Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study.
  9. Participant has evidence of corneal opacification or lack of optical clarity.
  10. Participant has uveitis or other ocular inflammatory disease.
  11. Participant is receiving systemic steroids or other immunosuppressive medications.
  12. Participant has diabetic macular edema and/or diabetic retinopathy.
  13. Participant has myopic degeneration.
  14. Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular or systemic administration.
  15. Participant is pregnant or lactating.
  16. Participant is on chemotherapy.
  17. Participant has a history of malignancy other than basal cell carcinoma, unless it was treated successfully 2 years prior to inclusion in the trial.
  18. Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
  19. Participant has choroidal neovascularization secondary to age related macular degeneration or any other type of retinal degeneration that may interfere with the study procedures, evaluations and outcome assessments.
  20. Any intraocular surgery of the study eye within 12 weeks prior to the screening visit
  21. History of use of drugs with known retinal toxicity, at retinotoxic doses.
  22. Participant has a history or current non-arteritic anterior ischemic neuropathy (NAION)
  23. Patient has a history of multiple sclerosis.
  24. Participant has glaucoma that is not considered open angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma..
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02862938
Other Study ID Numbers  ICMJE 37202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey L Goldberg, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP